Sealed connection device for medical use of the luer lock type and syringe incorporating such a device

ABSTRACT

Luer lock type connection device for medical use having a nozzle in which an axial internal passage is formed. The nozzle includes a bearing connection surface and a proximal annular retention zone. The connection device also has a flange forming an axial open seat having a wall that includes a distal part with internal screw thread, and a transverse proximal part in which a central proximal retention opening is formed, and whose diameter is matched to that of the proximal annular zone of the nozzle. The proximal annular retention zone of the nozzle and/or the central proximal retention opening of the flange include a circular band or cord covered or treated with a roughening agent.

The present invention pertains to connection devices for medical use, and more particularly to devices of the Luer-lock type.

The device that is the object of the present invention comprises in general:

-   -   a) An adapter provided with an axial passage; this adapter         includes a juncture seat, for example an external distal seat         fitted by friction, e.g., of a frustoconical shape, and a         proximal annular retention zone, consisting of a flat-bottomed         groove for example;     -   b) An attached collar, providing an axial and distal open         housing, the wall of which comprises a distal part with an         internal threading and a proximal part in which a central         proximal opening is provided; the diameter of this opening is         adjusted to that of the proximal annular zone of the adapter;         the collar is attached or connected in a translational and/or         rotational manner to the adapter, by insertion between the         proximal annular retention zone of the adapter on the one hand         and the proximal central retention zone on the other;     -   c) A connection device comprising another additional junction         seat, e.g., an internal friction-fitted seat, adjusted to fit         the junction seat of the adapter; this device has at least one         proximal and transverse external flange, forming a thread         adjusted to the internal threading of the collar, with an axial         passage in fluid communication with the interior of the cap.

Such a device is more particularly associated with a syringe, which also traditionally comprises a hollow body forming a chamber for a liquid to be ejected or drawn into the said syringe, a sealant joint provided on the inside of the body to delimit the said chamber, and a plunger-forming joint activator rod, disposed in the rest of the chamber with a proximal gripping part.

When a connection device such as that previously defined is combined, for example, with a syringe:

-   -   on the one hand, the distal end of the chamber-forming body is         shaped according to the adapter defined in paragraph a) above of         the preceding general definition, with the collar being         connected or attached to this adapter, as defined in         paragraph b) above of the preceding general definition,     -   on the other hand, a needle assembly forming a connection device         such as that defined in paragraph a) above of the preceding         general definition, wherein the needle forms the axial passage         in fluid communication with the interior of the said device.

In general, a syringe such as that previously defined is supplied to the user, e.g., medical personnel, in two parts, i.e.:

-   -   a first part consisting of the syringe strictly speaking, of         glass or plastic material, discardable or reusable, prefilled or         not;     -   and the needle assembly, such as defined previously, contained         at least partially in a protective cover in order to prevent any         accidental contact between the tip of the needle and the user;         means disposed between the outside of the cap and the inside of         the cover making it possible to wedge in the needle assembly so         that it rotates in the cover, wherein these means may consist of         longitudinal ribs cooperating with longitudinal slots; in its         proximal part, the cover may also comprise a collar-receiving         retainer connected and attached to the adapter of the syringe.

These two components are handled as follows.

The user connects the cover retainer with the syringe collar and consequently the cap with the axial housing of the collar, doing so in such a manner as to achieve alignment along an axis common to the syringe with its collar, the needle assembly, and the protective cap.

By screwing the outer flange of the cap of the syringe assembly into the axial housing of the collar, a friction-activated connection is achieved between the internal distal seat of the cap and the external distal seat of the adapter; such a coupling cannot be split apart by pulling the needle assembly from the syringe strictly speaking, taking into account the fact that the collar and the cap are assembled by screwing.

After the screwing is completed and thus the friction-activated coupling has been achieved, it is possible, simply by pulling, to remove the protective cover.

The present invention has as its object to improve the previously defined Luer-lock, and more precisely to prevent any untimely disconnection under any circumstance, particularly when all or part of the connection device enters into contact with a liquid or oily material.

In accordance with the present invention, it has been discovered that when the proximal annular retention zone of the adapter and/or the proximal central retention opening of the collar comprise a circular band or cord coated by a roughening agent, it becomes difficult and even impossible to make the collar rotate around the adapter when the cap and the said collar have been screwed together on the one hand and to disengage the collar from the adapter when the protective cover is removed from the cap, on the other.

The present invention also comprises the following exemplified embodiments.

Preferably, the proximal annular retention zone of the adapter is a flat-bottomed groove, and the central retention opening of the collar forms a circular edge, adjusted to be locked into this groove; in this case, for example, the roughening agent coats the flat bottom of the groove and/or the edge of the central opening.

The roughening agent comprises particles of an inert and abrasive material, e.g., of ceramic, preferably encrusted and bound to the surface of the above-mentioned circular band.

The particles of inert and abrasive material are preferably bound by a binder coating the circular band.

The roughening agent, in the form of particles, can be deposited or supplied in the form of a circular band or cord, either in the proximal annular retention zone of the adapter or in the proximal central retention opening of the collar, by any appropriate means, such as sprinkling in the form of a powder, e.g., electrostatic dusting, brushing, etc.

However, preference will be given to any process consisting of forming a solution or suspension of the binder in an appropriate liquid medium, of coating the above-mentioned circular band with the binder and the particles of the roughening agent in suspension or solution, and then of eliminating the liquid medium. In this regard, and for all practical purposes, reference is made to the processes described in document U.S. Pat. No. 4,589,871.

The roughening agent can be applied to the surface of the band forming contact between the collar and the adapter according to any appropriate system, e.g., in a continuous manner, in strips, or by stippling.

The roughening agent may be a physical means making it possible to obtain the roughness sought on the circular band forming contact between the collar and the adapter. Such a physical means may consist of abrasion with an airflow under pressure carrying abrasive particles, or a laser beam.

The present invention is now described in reference to the attached drawing, in which:

FIG. 1 represents a Luer-lock type syringe, not connected to the needle assembly;

FIG. 2 represents the same syringe connected to a needle assembly, protected by a protective cover;

FIG. 3 represents the connection device strictly speaking, in axial view, before assembly;

FIG. 4 represents the same device, still in axial view, after connection has been accomplished between the needle and the collar on the one hand and the cap equipped with the axial passage or needle on the other.

The present invention is now described in reference to a syringe comprising in general:

-   -   A syringe 20 strictly speaking;     -   And a needle assembly 30, provided with a protective cover 31.

The syringe 20 traditionally comprises:

-   -   A body 21, manufactured of glass or a plastic material;     -   A sealant joint 22 forming a plunger, and with the rest of the         body 21 delimiting a chamber 23 of varying volume for the liquid         or fluid to be ejected or drawn;     -   A rod 24 disposed coaxially to the body 21, comprising a         proximal handling end 24 a, and a distal end 24 b attached to         the joint 22, e.g., by screwing.

The needle assembly 30 comprises:

-   -   A connection device 8, the distal part of which forms an         arrangement 8 a with longitudinal ribs 8 b to accommodate         rotational wedging;     -   A needle or axial passage 13 in one piece with the cap, in fluid         communication with the inside of the said cap;     -   A protective cover 31, closed at its distal end 31 a, producing         an axial passage 31 a for needle 13, and provided with         longitudinal slots 31 b respectively for the reception or         insertion of ribs 8 b; the cover also comprises a flared         proximal part 31 a.

The connection device 1 strictly speaking, accompanied on the one hand by the needle assembly 30 and on the other by the syringe 20 equipped with its collar 5, is described below.

This sealant connection device thus comprises:

-   -   a) An adapter 2 forming the axial end of body 21 of syringe 20,         in which an internal axial passage 2 a is provided; this adapter         comprises an external distal seat 3 with sealant coupling, i.e.,         a friction-activated connection, e.g., of a frustoconical shape,         and a proximal annular retention zone 4, consisting, for         example, of a flat-bottomed groove 4 a;     -   b) A collar 5, e.g., of injected plastic material, providing an         open axial housing 5 a; the wall 6 of this collar comprises a         cylindrical distal part 6 a with an internal threading 12, and a         proximal part 6 b in which a proximal central opening 7 is         provided; this central retention opening forms a circular edge 7         a, the diameter of which is adjusted to that of the proximal         annular zone 4 of the adapter 2, which permits the collar 5 to         be locked into the proximal annular retention zone 4 or         flat-bottomed groove of adapter 2; thus, collar 5 is attached in         a translational and/or rotational manner to adapter 2, by         insertion between this annular zone 4 or groove and the central         proximal opening 7, and more precisely the edge 7 a of the         collar 5;     -   c) A connection device 8 comprising another additional, internal         junction seat 9, e.g., of a frustoconical shape, i.e., with         coupling by friction, fitted to the external distal coupling         seat 3 of adapter 2; this device also comprises two proximal and         transverse external and radial flanges 10, together forming a         thread 11 fitted to the internal threading 12 of the collar 5;         and as indicated previously, the axial needle 13 is in fluid         communication with the interior of the cap 8.

In accordance with the present invention, the proximal annular retention zone 4 of adapter 2, e.g., the flat-bottomed groove 4 a, and/or the central retention opening 2 of the collar 5, or the circular edge 7 a, comprise a circular band 4 a coated with or treated by a roughening agent; preferably this roughening agent coats the flat bottom 4 a of the groove, and/or the edge 7 a of the central opening 7.

The operation of the connection device may be deduced from comparing the illustrations shown in FIGS. 3 and 4, and has been explained in the introductory part of the present description.

Thanks to the roughening agent, a complete and ensured connection of the needle assembly 30 to the adapter 2 of the syringe 20 is achieved.

Different variants of the solution according to the invention may be considered:

-   -   The proximal annular retention zone 4 of the adapter may be         different from a groove; in the case of a groove, the latter may         have a concave or angular base;     -   The roughening agent may consist of a system for grinding an         originally smooth surface by abrasion or chemical attack, and         may also consist of an adhesive applied by any appropriate         means. 

1. Connection device for medical use, of the Luer lock type, comprising: a) An adapter (2) having an axial internal passage (2 a), comprising a junction seat (3) and a proximal annular retention zone (4); b) A collar (5) providing an axial open housing (5 a) whose wall (6) contains a distal part (6 a) with internal threading (12) and a transverse proximal part (6 b) in which provision is made for a proximal central retention opening (7), whose diameter is adjusted to that of the said proximal annular zone (4) of the adapter (2), wherein the said collar (5) is attached in translational or rotational manner to the adapter (2), by insertion between the proximal annular retention zone (4) of the said adapter and the proximal central retention opening (7); c) A connection device (8) comprising another additional junction seat (9), fitted to the junction seat (3) of the adapter (2), and at least one external proximal, transverse flange (10), forming a thread (11) fitted to the internal threading (12) of the collar (5), with an axial passage (13) in fluid communication with the interior of the said cap (8), characterized by the fact that one of the proximal annular retention zone (4) of the adapter (2) and the proximal central retention opening (7) of the collar (5) contain a circular band or cord (4 a) coated or treated with a roughening agent, further characterized by the fact that the proximal annular retention zone (4) of the adapter (2) is a groove with a flat bottom (4 a), and the central retention opening (7) of the collar (5) forms a circular edge (7 a) fitted to lock into the said groove, and further characterized by the fact that the roughening agent coats the flat bottom (4 a) of the groove and/or the edge (7 a) of the central opening.
 2. Connection device for medical use, of the Luer lock type, comprising: an adapter (2) having an axial internal passage (2 a), comprising a first junction seat (3) and a proximal annular retention zone (4); a collar (5) providing an axial open housing (5 a) whose wall (6) contains a distal part (6 a) with internal threading (12) and a transverse proximal part (6 b) in which provision is made for a proximal central retention opening (7), whose diameter is adjusted to that of the said proximal annular zone (4) of the adapter (2), wherein the said collar (5) is attached in translational or rotational manner to the adapter (2), by insertion between the proximal annular retention zone (4) of the said adapter and the proximal central retention opening (7); a connection device (8) comprising a second junction seat (9), fitted to the first junction seat (3) of the adapter (2), and an external proximal, transverse flange (10), forming a thread (11) fitted to the internal threading (12) of the collar (5), with an axial passage (13) in fluid communication with the interior of the said can (8); characterized by the fact that one of the proximal annular retention zone (4) of the adapter (2) and the proximal central retention opening (7) of the collar (5) contain a circular band or cord (4 a) coated or treated with a roughening agent; further characterized by the fact that the proximal annular retention zone (4) of the adapter (2) is a groove with a flat bottom (4 a), and the central retention opening (7) of the collar (5) forms a circular edge (7 a) fitted to lock into the said groove; further characterized by the fact that the roughening agent coats the flat bottom (4 a) of the groove and/or the edge (7 a) of the central opening; further characterized by the fact that the roughening agent comprises particles of an inert and abrasive material, preferably encrusted and bound to one of the surface of the circular band (4 a) and the edge (7 a).
 3. Device according to claim 2, characterized by the fact that the particles of the inert and abrasive material are bound by a binder coating one of the circular band (4 a) and the edge (7 a).
 4. Connection device for medical use, of the Luer lock type, comprising: an adapter (2) having an axial internal passage (2 a), comprising a first junction seat (3) and a proximal annular retention zone (4); a collar (5) providing an axial open housing (5 a) whose wall (6) contains a distal part (6 a) with internal threading (12) and a transverse proximal part (6 b) in which provision is made for a proximal central retention opening (7), whose diameter is adjusted to that of the said proximal annular zone (4) of the adapter (2), wherein the said collar (5) is attached in translational or rotational manner to the adapter (2), by insertion between the proximal annular retention zone (4) of the said adapter and the proximal central retention opening (7); a connection device (8) comprising a second junction seat (9), fitted to the first junction seat (3) of the adapter (2), and an external proximal, transverse flange (10), forming a thread (11) fitted to the internal threading (12) of the collar (5), with an axial passage (13) in fluid communication with the interior of the said cap (8); characterized by the fact that one of the proximal annular retention zone (4) of the adapter (2) and the proximal central retention opening (7) of the collar (5) contain a circular band or cord (4 a) coated or treated with a roughening agent; further characterized by the fact that the proximal annular retention zone (4) of the adapter (2) is a groove with a flat bottom (4 a), and the central retention opening (7) of the collar (5) forms a circular edge (7 a) fitted to lock into the said groove; further characterized by the fact that the roughening agent coats the flat bottom (4 a) of the groove and/or the edge (7 a) of the central opening; further characterized by the fact that the junction seat (3) has a frustoconical shape. 